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MICHAEL G. ECKSTEIN
Nearly thirty years as a proven leader (CEO, COO, President) and operations executive (CTO, CIO) in the pharmaceutical/ biotechnology/ healthcare/ clinical trial industries. Extensive business development and full P&L responsibilities ranging from Fortune 500 assignments to start-up and emerging growth companies. A proven, demonstrated track record of building infrastructures, growing companies and launching products.
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Since 1991, M. Eckstein has served as a senior consultant…for both short term and multi-year assignments…to various Fortune 100 global corporations to formulate and implement various life science, clinical trial and IT initiatives. Successfully executed 70+ total engagements.
Engaged by a prominent California pharmaceutical company to organize, coordinate, negotiate and manage all clinical trial contacts, regulatory and budget documents throughout 27 different clinical sites in 4 EU countries. With an average of 4+ contracts per site, an effective check-and-balance structure with the General Counsel of the Sponsor Company, successfully managed over 115 CTAs and related documents.
Provided on-going business development, strategy creation and tactical implementation support to a leading Massachusetts clinical trial patient recruitment company to achieve its worldwide growth and global expansion efforts. This included multi-country incorporation analysis, partner and alliance contract negotiations, and new product design and launch responsibilities.
Delegated by a major California biotechnology company all outsourced responsibilities to provide senior management and leadership oversight for all international clinical trial contracts and supporting documents. This included the management of internal and outsourced resources to expedite site initiation at 300+ clinical sites around the world.
Provided QA/QC check-and-balance services against all CRO presented site templates and contracts for EU activities. Reporting to the General Counsel, contact and negotiations with all sites regarding localized modifications to boilerplate clinical trial contracts and documents were managed.
Provided 15 months of hands-on guidance and direction in the drafting of a master global CTA document and, with affiliates and alliance partners in 40+ countries, coordinated the customization of each CTA per the clinical trial laws and regulations of the specific country.
Acted as the interim CEO for a massive repositioning branding project. Roles and responsibilities included all start-up activities, staffing, marketing program development, all IT technical oversight, forging key business alliances, and full budgetary P&L responsibility. The project was eventually spun off as a fully funded, standalone entity with $40 million in investment capital. |
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